Quality Assurance Specialist (177-178) Salient Surgical Technologies, Inc.
tion
Assists in executing various functions of Quality Assurance and Quality Engineering such as inspection and testing, calibration, procedure writing and updating, quality compliance and documentation.
Essential Duties and Responsibilities:
Assists in maintaining current calibration on measuring and test equipment, including maintaining calibration log and scheduling calibration activities as required.
Manages supplier qualification and requalification activities. Maintains Salient Surgical Technologies Approved Supplier List.
Performs product related Quality functions, as needed, such as bio-approval of materials, accelerated aging coordination and testing, and packaging qualifications.
Responsible for Incoming Inspection activities including initiation of test plans and component release.
Reviews inspection test data and releases product for sale.
Tracks Engineering Changes and follows up on open action items.
Dispositions Returned Goods and provides necessary documentation.
Initiates and/or updates quality procedures, work instructions, test plans or other documentation.
Assists with quality engineering support of Contract Manufacturers as required. Activities may include process and equipment verification / validation, production line audits, follow through on Supplier Corrective Actions etc.
Participates in Internal Quality Audit
Required Skills
Required Skills and Experience:
Knowledge of Microsoft Word and Excel.
Knowledge of statistics for quality data analysis desirable.
Knowledge of general inspection and test equipment.
Ability to communicate effectively, orally and in writing.
Ability to write protocols and procedures.
High capacity to multi-task.
Basic understanding of blueprints
Required Experience
Education and experience:
Bachelors Degree in Engineering, Medical, Science or other related field.
Two to Five years experience in Quality and/or Manufacturing environment
Familiarity with ISO 13485 and FDA Quality System Regulations.
| Location: |
Portsmouth, NH
United States
|